Last Updated : August 27, 2020
Details
FilesGeneric Name:
icosapent ethyl
Project Status:
Complete
Therapeutic Area:
Ischemic events in statin-treated patients
Manufacturer:
HLS Therapeutics
Call for patient/clinician input open:
Brand Name:
Vascepa
Project Line:
Reimbursement Review
Project Number:
SR0619-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC
Performance Metric:
N/A delay outside our control - Application held awaiting decision by Health Canada
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
To reduce the risk of cardiovascular events (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, coronary revascularization or hospitalization for unstable angina) in statin-treated patients with elevated triglycerides, who are at high risk of cardiovascular events due to: established cardiovascular disease, or diabetes, and at least one other cardiovascular risk factor.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Ischemic events in statin-treated patients
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation:
- The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of Canada's Drug Agency. Reimbursement criteria from Canada's Drug Agency will be documented in the final recommendation, if applicable.
Key Milestones2 |
|
|---|---|
| Call for patient input posted | May 17, 2019 |
| Patient group input closed | July 09, 2019 |
| Clarification:
- No patient input submission received |
|
| Submission received | June 17, 2019 |
| Submission accepted | July 02, 2019 |
| Review initiated | July 03, 2019 |
| Clarification:
- Submission temporarily suspended pending receipt and review of information - Additional information has been received and the temporary suspension of the review has been lifted |
|
| Draft CADTH review report(s) sent to sponsor | October 22, 2019 |
| Comments from sponsor on draft CADTH review report(s) received | October 31, 2019 |
| CADTH review team's comments on draft CADTH review report(s) sent to sponsor | November 29, 2019 |
| Canadian Drug Expert Committee (CDEC) meeting | December 11, 2019 |
| CDEC recommendation sent to sponsor and drug plans | January 16, 2020 |
| Embargo period ended | February 28, 2020 |
| Clarification:
- Request for extension to embargo period received from the sponsor - Embargo extension request granted - Reconsideration requested |
|
| Sponsor's request for reconsideration placed on CDEC agenda | May 20, 2020 |
| Clarification:
- Deferred to June 17, 2020 CDEC meeting |
|
| CDEC recommendation sent to sponsor and drug plans | June 24, 2020 |
| Embargo period ended | July 09, 2020 |
| CDEC Final Recommendation & CADTH review report(s) issued to sponsor and drug plans | July 16, 2020 |
| CDEC Final Recommendation posted | July 20, 2020 |
| Redaction requests from sponsor on draft CADTH review report(s) received | July 30, 2020 |
| Redacted CADTH review report(s) sent to sponsor and drug plans | August 12, 2020 |
| Validation of redacted CADTH review report(s) received | August 19, 2020 |
| Final CADTH review report(s) posted | August 26, 2020 |
Files
Last Updated : August 27, 2020